Usage
Alfuzosin + Dutasteride is prescribed for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men. BPH is a non-cancerous enlargement of the prostate gland, which can lead to urinary problems. This combination therapy helps relieve lower urinary tract symptoms (LUTS) associated with BPH, such as difficulty urinating, weak urine stream, and frequent or urgent urination.
It is classified as a combination of an alpha-1 adrenergic receptor blocker (Alfuzosin) and a 5-alpha reductase inhibitor (Dutasteride).
Alfuzosin works by relaxing the smooth muscles in the prostate and bladder neck, reducing resistance to urine flow. Dutasteride inhibits the enzyme 5-alpha reductase, which converts testosterone to dihydrotestosterone (DHT). DHT is a hormone that plays a role in prostate growth, so reducing DHT levels helps shrink the prostate gland.
Alternate Names
This combination is often referred to as Alfuzosin/Dutasteride. Brand names include Alfugress D and Alfusin D.
How It Works
Pharmacodynamics: Alfuzosin relaxes the smooth muscles in the prostate and bladder neck, improving urine flow. Dutasteride inhibits the conversion of testosterone to DHT, shrinking the prostate gland over time and further alleviating BPH symptoms.
Pharmacokinetics:
- Alfuzosin: Alfuzosin is well absorbed after oral administration, with peak plasma concentrations occurring in about 8 hours with extended-release formulations. It is extensively metabolized by the liver and primarily excreted in the feces. The half-life is approximately 12 hours for the extended-release form.
- Dutasteride: Dutasteride is also well absorbed after oral administration, reaching peak serum concentrations within 1 to 3 hours. It is highly protein-bound and extensively metabolized by CYP3A4 in the liver. Dutasteride has a long half-life of approximately 5 weeks.
Mode of Action:
Alfuzosin acts as a selective alpha-1A adrenergic receptor blocker, primarily in the prostate, prostatic capsule, prostatic urethra, and bladder neck. By blocking these receptors, it relaxes smooth muscle tone and reduces urethral resistance, which improves urine flow and reduces BPH symptoms. Dutasteride inhibits both type 1 and type 2 isoforms of the 5-alpha-reductase enzyme, blocking the conversion of testosterone to DHT. Lowering DHT levels leads to a reduction in prostate size, which further alleviates BPH symptoms.
Elimination Pathways: Alfuzosin is primarily eliminated through hepatic metabolism followed by fecal excretion. A small portion is excreted unchanged in urine. Dutasteride is primarily eliminated via hepatic metabolism with a small amount excreted in feces.
Dosage
Standard Dosage
Adults:
The standard dose is one tablet containing 10 mg alfuzosin extended-release and 0.5 mg dutasteride, taken orally once daily.
Children:
This medication is not indicated for use in children.
Special Cases:
- Elderly Patients: No dosage adjustment is typically required.
- Patients with Renal Impairment: No dosage adjustment is needed for mild to moderate renal impairment. Caution is advised in severe renal impairment.
- Patients with Hepatic Dysfunction: Use with caution in patients with mild to moderate hepatic impairment. It is contraindicated in severe hepatic impairment.
- Patients with Comorbid Conditions: Caution should be exercised in patients with cardiovascular disease, especially those taking antihypertensive medications, as the combination may cause hypotension.
Clinical Use Cases
Alfuzosin + Dutasteride is specifically indicated for the management of BPH and not for other clinical use cases like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations.
Dosage Adjustments
Dose adjustments are usually not necessary for elderly patients or those with mild to moderate renal impairment. In cases of hepatic dysfunction, careful consideration is required, and dose adjustments or avoidance may be necessary depending on the severity. Patients with cardiovascular disease or taking certain medications might require dose adjustments to avoid hypotension.
Side Effects
Common Side Effects:
Dizziness, lightheadedness, headache, asthenia (weakness or lack of energy), postural hypotension (low blood pressure upon standing), rhinitis (inflammation of the nasal lining), ejaculation disorders, decreased libido, impotence.
Rare but Serious Side Effects:
Angioedema (severe swelling of the face, lips, tongue, or throat), syncope (fainting), chest pain, priapism (prolonged and painful erection), allergic reactions.
Long-Term Effects:
Gynecomastia (breast enlargement or tenderness in males), persistent sexual dysfunction.
Adverse Drug Reactions (ADR):
Severe hypotension, angioedema, syncope.
Contraindications
Hypersensitivity to alfuzosin, dutasteride, or any components of the formulation. Severe hepatic impairment. Use in women, children, and pregnant or breastfeeding women. Concomitant use with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).
Drug Interactions
CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir), other alpha-blockers (e.g., prazosin, tamsulosin, terazosin, doxazosin), PDE5 inhibitors (e.g., sildenafil, tadalafil), antihypertensive medications, alcohol.
Pregnancy and Breastfeeding
Contraindicated in women of childbearing potential, including pregnant and breastfeeding women. Dutasteride can cause harm to a male fetus.
Drug Profile Summary
- Mechanism of Action: Alfuzosin: Alpha-1 adrenergic receptor blocker, relaxing smooth muscles in prostate and bladder. Dutasteride: 5-alpha reductase inhibitor, reducing DHT levels and shrinking prostate size.
- Side Effects: Dizziness, headache, hypotension, rhinitis, ejaculation disorders, decreased libido, impotence. Rarely: angioedema, syncope, chest pain, priapism, allergic reactions.
- Contraindications: Hypersensitivity, severe hepatic impairment, use in women and children, concomitant use with potent CYP3A4 inhibitors.
- Drug Interactions: CYP3A4 inhibitors, other alpha-blockers, PDE5 inhibitors, antihypertensives, alcohol.
- Pregnancy & Breastfeeding: Contraindicated.
- Dosage: One tablet (10 mg alfuzosin ER / 0.5 mg dutasteride) orally once daily.
- Monitoring Parameters: Blood pressure, PSA levels, liver function tests.
Popular Combinations
Not applicable. This medication is itself a combination product.
Precautions
Monitor blood pressure, especially at the initiation of therapy. Evaluate for prostate cancer before starting treatment. Inform patients about the risk of intraoperative floppy iris syndrome (IFIS) during cataract surgery. Advise caution when driving or operating machinery due to potential dizziness. Use caution with hepatic impairment.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Alfuzosin + Dutasteride?
A: One tablet (10 mg alfuzosin extended-release / 0.5 mg dutasteride) orally once daily.
Q2: How long does it take to see improvement in BPH symptoms?
A: It may take several weeks or even up to 6 months to experience the full benefit of this medication.
Q3: Can women take Alfuzosin + Dutasteride?
A: No, this medication is contraindicated in women.
Q4: What are the most common side effects?
A: Dizziness, lightheadedness, headache, asthenia, postural hypotension, rhinitis, ejaculation disorders, and decreased libido.
Q5: Does Alfuzosin + Dutasteride cure BPH?
A: No, this medication helps manage the symptoms of BPH but does not cure the condition.
Q6: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it is almost time for your next dose. Do not double the dose.
Q7: Can I take this medication with alcohol?
A: Alcohol may increase the risk of side effects such as dizziness and hypotension. It’s advisable to limit or avoid alcohol consumption while taking this medication.
Q8: Should I stop taking this medication before cataract surgery?
A: No, there is no evidence to suggest stopping the medication before cataract surgery. Inform your ophthalmologist about your use of Alfuzosin + Dutasteride, as they may need to adjust the surgical technique.
Q9: Does this medication affect fertility?
A: Decreased libido and ejaculation disorders are potential side effects. While there’s no definitive evidence of long-term effects on fertility, consult a doctor for any concerns.
